NCT01229345

Brief Summary

The purpose of this study is to assess the effect of eating breakfast in combination with exercise on fat usage, appetite and brain performance later in the day.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

October 12, 2010

Last Update Submit

May 2, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy balance

    Energy balance (kJ/kcal) will be assessed by an ad libitum test meal provided at 5 h minus energy expenditure estimated by indirect calorimetry.

    24 h

Secondary Outcomes (6)

  • Blood glucose

    1.5 h area under the curve, post-consumption of a liquid snack

  • Serum insulin

    1.5 h area under the curve, post-consumption of a liquid snack

  • Subjective appetite ratings

    1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal

  • Cognitive function measurements

    1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal

  • Mood

    1.5 h area under the curve, post-consumption of a liquid snack and following an ad libitum test meal

  • +1 more secondary outcomes

Study Arms (4)

Breakfast & exercise

EXPERIMENTAL
Drug: Breakfast & exercise

Breakfast & no exercise

EXPERIMENTAL
Drug: Breakfast & exercise

No breakfast & exercise

EXPERIMENTAL
Drug: Breakfast & exercise

No breakfast & no exercise

NO INTERVENTION

Interventions

1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.

Breakfast & exerciseBreakfast & no exerciseNo breakfast & exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Aged 18-45 years
  • BMI 18.5-24.9 kg/m2
  • Physically active: able to run for 1 h at a moderate pace
  • Healthy

You may not qualify if:

  • Smokers
  • Food allergies
  • Metabolic disorders
  • Restrained eaters (equivalent of \>7 for restrained on TFEQ)
  • Consuming herbal/dietary supplements
  • History of head trauma
  • Learning difficulties
  • ADHD
  • Dyslexia
  • History of migraines
  • Gastric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain, Performance and Nutrition Centre, Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

BreakfastExercise

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emma J Stevenson, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 27, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations